Earl Hulihan

Profile Updated: April 11, 2017
Earl Hulihan
Residing In Bangor, PA USA
Spouse/Partner Donna
Homepage View Website
Occupation Professor of Medicine and Consultant to several global Regulatory Authorities
Children Son Christian b.1972, Daughter-in-law Corrie, Grandchildren Anna and Ellie (5 & 3 years respectfully)
Daughter More…Meghan b.1976, Son-in-law Jeff and Grandson Jeremiah (21 years old)
Earl Hulihan

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Proud of being a Husband, Father and Grandfather with close relationships together; a Conservative and Independant; a wonderful Professional life with opportunities such as serving on US Olympic Committee; Co-Developer of Special Olympics program (with Shriver and Kennedy family members); 40 years on faculty of Rutgers Medical School and currently with Professorships in US and China Medical Schools. American Heart Association Board of Directors with Gold Medal for Service; Awarded by my Alma Mater University their Outstanding Alumnus Award.
Travel extensively around the globe teaching and advising - Consultant to 5 National Regulatory Authorities currently (down from 19).
Enjoy vacations on Prince Edward Island, Ireland and Netherlands ... and time with Grandchildren.

School Story

My favorite 'story' was being 'encouraged' by Mr. Trimble and Counselors to "not" consider college in my future - but consider a career in 'entertainment'. Paul Westhead really had 180 degree guidance and encouragement for me. I did take Mr. Westhead's advice. As a result, I have had an Award winning lifelong career in Medicine (Cardiology, Neuroscience). I do wonder this ... if Vaudeville had continued, I might have chosen that as a career ... or the French Foriegn Legion. lol

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Posted on: Apr 11, 2017 at 4:10 AM

Hey, is there one near you now? Lee's. http://leeshoagiehouse.com

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Earl Hulihan has left an In Memory comment for TED HELLER.
May 15, 2016 at 4:33 PM

 I am deeply sorry about Ted. Does anyone know any of the specifics? Please comment ...

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Professor Hulihan is Owner of the Professor Earl W. Hulihan Consultancy, LLC, an internationally recognized provider of advice and consultation to the global regulatory community, as well as the pharmaceutical, biotech and medical device industry. In addition, Hulihan currently provides advice and training to regulatory authority personnel within the North American, Latin American, European and APAC communities (currently 16 countries globally). As recently as 2012 and 2016, Hulihan was recognized as an “expert in his field” as well as a “scientific expert” by several of these same regulatory authorities. The knowledge and experiences gained from over 800 ‘GXP’ international Audits is a testament to his domain’s strength of knowledge, experience, reputation and character. Professor Hulihan has functioned in the Global GXP Regulatory Environment for over 40 years, primarily in the areas of Quality Assurance, Regulatory Affairs, Clinical Research, Drug Development, Drug Safety and Quality Systems. This includes Senior Quality Assurance positions in the Global Pharmaceutical Environment [Pharma. CRO, and Vendor] as well as over 22 years in Clinical Medicine and Clinical Research at Rutgers, The State University’s School of Medicine. Clinical areas of involvement included Cardiovascular, Pulmonary, and Endocrine areas of Medicine as well as Psychiatry.
Professor Hulihan has been active in medicine and the pharmaceutical industry since the mid 1970’s and is often called upon to speak and serve as chair in many International conferences. He is active in the Drug Information Association (DIA) and serves on the Editorial Board of the Guide to Good Clinical Practice and Expert Advisory Panel for Good Clinical Practice: A Question & Answer Reference Guide. Since the mid 1970’s, Hulihan has been one of the leaders internationally in Data Integrity and Data Quality initiatives in Medicine and the pharmaceutical industry. Hulihan is also a Contributing Author to several textbooks; New Drug Approval Process (3rd, 4th, 5th and 6th editions) with chapters on Quality Assurance, China and HIPAA, Good Clinical Practice: A Question & Answer Reference Guide (2008 though 2016 editions) with chapters on cGCPs in Latin America, Canada, Russia and China, co-editor of the Global GLP reference book, Computerized Systems in Nonclinical Safety Assessment: Current Concepts in Validation and Compliance (a.k.a. Red Apple II) (2008) and Editor of the Global GCP reference book, Computerized Systems in Clinical Research: Current Quality and Data Integrity Concepts (a.k.a. Peach) and reviewer for the Journal of Medical Systems for many years. He has also authored numerous journal articles during his career. During the early 1970's, Hulihan collaborated with one of the fathers of sports medicine, Dr. Hans Kraus, in the development of a new global clinical program for the “Prevention and Treatment of Back Ache, Stress and Tension.” Also, during the 1970's, Hulihan collaborated in writing the Special Olympics Program (an internationally recognized program for persons with intellectual disabilities). The Joseph P. Kennedy Foundation acknowledged Hulihan with a special award. He has achieved other significant honors from diverse International organizations including Who’s Who (Computer industry as well as Executives and Professionals), the American Heart Association’s Distinguished Honors Award and the Drug Information Association’s two highest honors – the prestigious Distinguished Service and the Founders Service Awards. Professor Hulihan currently serves as an Associate Professor with Rutgers University School of Medicine (USA), a Visiting Professor with the prestigious Shanghai University of Traditional Chinese Medicine (China) and as a Professor with the China Food and Drug Administration’s Institute of Executive Development. Professor Hulihan is the First Westerner ever appointed to a Professorship at either SUTCM or the CFDA Institute.
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Personal: Interests include: 1) Family (including Genealogy), 2) Military History (especially the Peloponnesian War (431-404 BCE), First and Second Carthaginian or Punic Wars (264 BCE to 146 BCE) and (218 BCE to 201 BCE) respectively, American Civil War (1862-1865 CE), 3) Biblical Archeology and Biblical Exegesis, 4) The very wonderful respites of Prince Edward Island, Canada, Ireland, Switzerland, and The Netherlands!

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